BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4499484 · Received February 10, 2015

    Report

    Report Number
    2649622-2015-01398
    Event Type
    Malfunction
    Date Received
    February 10, 2015
    Date of Event
    December 12, 2014
    Report Date
    December 12, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THERE WAS DIFFICULTY PLACING THE LEAD IN THE ATRIUM AND GETTING THE J TO FORM. WHEN THE LEAD WAS PULLED OUT IT WAS NOTED THAT THE STYLET WOULD NOT GO ALL THE WAY TO THE TIP OF THE LEAD. ANOTHER STYLET WAS ATTEMPTED, HOWEVER IT WOULD NOT GO TO THE TIP OF THE LEAD EITHER. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99568 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR